Maureen O’Connell
About Maureen O’Connell
Maureen O’Connell is the Senior VP of Clinical & Regulatory Affairs with over 30 years of experience in medical device regulatory affairs and clinical study management.
Senior VP, Clinical & Regulatory Affairs
Maureen O’Connell serves as the Senior Vice President of Clinical and Regulatory Affairs. In this role, she is responsible for overseeing the regulatory compliance and clinical strategy for medical devices. Her extensive experience spans more than three decades, providing her with deep insights into the regulatory landscape and clinical study management processes.
Over 30 Years of Experience in Medical Device Regulatory Affairs
Maureen O’Connell has accumulated over 30 years of experience in the field of medical device regulatory affairs and clinical study management. Her extensive career has equipped her with comprehensive knowledge and experience in handling regulatory compliance and overseeing clinical trials for medical devices.
Founder of O’Connell Regulatory Consultants
In 1997, Maureen founded O’Connell Regulatory Consultants, a firm specializing in strategic planning, preparation, and administration of premarket device submissions along with associated clinical trials. The consultancy has built a reputation for providing expert guidance and effective solutions for navigating the regulatory landscape for medical devices.
Executive Roles at Summit Technology, Inc.
From 1988 to 1997, Maureen O’Connell held executive regulatory and clinical roles at Summit Technology, Inc., a company known for its laser products. During her tenure, she contributed significantly to the company's regulatory strategies and clinical affairs, ensuring compliance with industry standards and facilitating successful product development and approval processes.
Bachelor of Science in General Management from Boston College
Maureen O’Connell is an alumna of Boston College, where she earned a Bachelor of Science degree in General Management with a concentration in Finance. Her educational background provides a solid foundation in management principles and financial acumen, which complement her extensive experience in clinical and regulatory affairs.